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NCT02633774 Clinical Trial

Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official title:
Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02633774
Other study ID # 4-2015-0914
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date November 2020

Study information
Verified date January 2019
Source Yonsei University
Contact Hui-Nam Park, MD, Ph.D
Phone 82-2-2228-8459
Email hnpak@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with persistent Atrial fibrillation (20~80 years old)

- LA diameter < 55mm

- patients possible to anticoagulation and anti arrhythmic drug

Exclusion Criteria:

- Structural cardiac disease

- Contraindication to brain perfusion CT

- Catheter ablation history for AF, Cardiac surgery

- active internal bleeding

- Impossible to anticoagulation or antiarrhythmic drug

- valvular AF ((MA> GII, Mechanical valve, Mitral valve replacement)

- LVEF < 30%

- With severe medical disease

- Expected survival < 1 year

- Severe alcoholics, drug addiction

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propafenone
AAD(antiarrhythmic drug)
• Apixaban
anti-coagulation

Locations
Country Name City State
Korea, Republic of Severance Cardiovascular Hospital, Yonsei University Health System Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary K-MOCA(Korean version of Montreal Cognitive Assessment) 12 months after the enrollment
Primary Brain perfusion CT 12 months after the enrollment
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